MAUDE Adverse Event Report: COOK IRELAND LTD UNKNOWN; FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 09/19/2023

Event Type  Injury  

Event Description

Morimoto 2023 - optimal liver drainage rate for survival in patients with unresectable malignant hilar biliary obstruction using 3d-image volume analyzer all patients underwent the procedure via a standard endoscopic retrograde cholangiopancreatography (ercp) technique using a standard duodenoscope (tjf-260, tjf-240, jf-260, or jf-260v; olympus optical co.Ltd., (b)(6) under intravenous sedation with meperidine hydrochloride and benzodiazepines.All patients underwent initial endoscopic biliary drainage with plastic stents (pss), and semss were replaced within 4 weeks after a definitive diagnosis of malignancy.The following semss were used: jostent selfx units (abbott vascular devices, redwood city, ca, usa), zilver stent (cook medical, winston-salem, nc, usa), zeo stent/ zeo stent v (zeon medical inc., chiyoda-ku, japan), niti-s biliary stent (taewoong medical co., gimpo-si, korea), and bilerush selective (piolax, yokohama, japan).All patients underwent more than two sems deployments using the partial stent-in-stent method,16 and 8-mm or 10-mm diameter semss were used depending on bile duct diameter.Endoscopic sphincterotomy (est) was performed to facilitate endoscopic reintervention for recurrent biliary obstruction (rbo) one case each of acute cholecystitis.Acute cholecystitis was improved after percutaneous transhepatic gallbladder drainage patient outcome: require intervention/additional procedures s=3 patient/event info - notes: gender male/ female: 50/40 age median years: 70.

Manufacturer Narrative

Pma/510(k) #k163018 investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

• Brand Name: UNKNOWN
• Type of Device: FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 19060438
• MDR Text Key: 339603616
• Report Number: 3001845648-2024-00150
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/19/2023
• Event Location: Hospital
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Male